Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 37 of 727 for:    Area Under Curve AND Bioavailability

Study to Estimate the Relative Bioavailability Compared to Commercial Extended-release Tablet Formulation and the Effects of Food Or Sprinkling on Applesauce for Fesoterodine Sustained-release Beads-in-capsule Formulations in Healthy Adult Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02160158
Recruitment Status : Completed
First Posted : June 10, 2014
Last Update Posted : January 15, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
The purpose of this study is to evaluate the relative bioavailability of 2 new bead-in-capsule formulations compared to the commercial extended-release formulation (both fed and fasted) and to assess the effect of sprinkling the capsule contents on applesauce on the pharmacokinetics of 5 hydroxymethyl tolterodine (5-HMT).

Condition or disease Intervention/treatment Phase
Healthy Drug: Fesoterodine ER (fasted) Drug: Fesoterodine SR3 (fasted) Drug: Fesoterodine SR3 (fed) Drug: Fesoterodine ER (fed) Drug: Fesoterodine SR3 (sprinkle) Drug: Fesoterodine SR4 (fasted) Drug: Fesoterodine SR4 (fed) Drug: Fesoterodine SR4 (sprinkle) Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Open-label, Single-dose, Randomized, Crossover Study To Estimate The Relative Bioavailability Compared To Commercial Extended-release Tablet Formulation And The Effects Of Food Or Sprinkling On Applesauce For Fesoterodine Sustained-release Beads-in-capsule Formulations In Healthy Adult Volunteers
Study Start Date : July 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cohort 1 Drug: Fesoterodine ER (fasted)
Commercial Fesoterodine ER 4 mg (single dose)

Drug: Fesoterodine SR3 (fasted)
Fesoterodine SR3 4 mg (single dose)

Drug: Fesoterodine SR3 (fed)
Fesoterodine SR3 4 mg (single dose) with high-fat meal

Drug: Fesoterodine ER (fed)
Commercial Fesoterodine ER 4 mg (single dose) with high-fat meal

Drug: Fesoterodine SR3 (sprinkle)
Fesoterodine SR3 4 mg (single dose) beads sprinkled on applesauce

Experimental: Cohort 2 Drug: Fesoterodine ER (fasted)
Commercial Fesoterodine ER 4 mg (single dose)

Drug: Fesoterodine SR4 (fasted)
Fesoterodine SR4 4 mg (single dose)

Drug: Fesoterodine SR4 (fed)
Fesoterodine SR4 4 mg (single dose) with high-fat/high calorie meal

Drug: Fesoterodine ER (fed)
Commercial Fesoterodine ER 4 mg (single dose) with high-fat meal

Drug: Fesoterodine SR4 (sprinkle)
Fesoterodine SR4 4 mg (single dose) beads sprinkled on applesauce




Primary Outcome Measures :
  1. Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] [ Time Frame: 48 hours ]
    AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.

  2. Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 48 hours ]

Secondary Outcome Measures :
  1. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: 48 hours ]
    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

  2. Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 48 hours ]
  3. Plasma Decay Half-Life (t1/2) [ Time Frame: 48 hours ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male and/or female subjects between the ages of 18 and 55 years; Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs)

Exclusion Criteria:

  • Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication
  • History of uncontrolled narrow angle glaucoma, myasthenia gravis, gastric retention, severe ulcerative colitis and toxic megacolon
  • Evidence or history of clinically significant urologic disease [urinary retention, obstructive disturbance of bladder emptying, micturition disturbance, nocturia or pollacisuria (eg, benign prostate hyperplasia, urethral stricture, recurrent urinary tract infections); Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes/day

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02160158


Locations
Layout table for location information
Belgium
Pfizer Clinical Research Unit
Brussels, Belgium, B-1070
Sponsors and Collaborators
Pfizer
Investigators
Layout table for investigator information
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02160158     History of Changes
Other Study ID Numbers: A0221099
2014-001248-39 ( EudraCT Number )
First Posted: June 10, 2014    Key Record Dates
Last Update Posted: January 15, 2015
Last Verified: January 2015
Keywords provided by Pfizer:
Fesoterodine
SR3
SR4
bioavailability
pharmacokinetics
sprinkle
applesauce
Additional relevant MeSH terms:
Layout table for MeSH terms
Fesoterodine
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents